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United States · US · US:71921-400_e4e6a5a8-f7be-4424-83f2-d6bb4d57443e
Dorzolamide Hydrochloride Ophthalmic
Orange BookUNIISPLATC S01EC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeS01EC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11719214001010 mL in 1 BOTTLE (71921-400-10)
Annotations
UNII (FDA Substance ID)
QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE
RxCUI 236065
Orange Book
A202053
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QZO5366EW7",
"rxcui": "236065",
"inchikey": "OSRUSFPMRGDLAG-QMGYSKNISA-N",
"display_name": "DORZOLAMIDE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"ff76c0cf-256c-4015-94f4-405f0c46205f": {
"match": "brand_token",
"title": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [BRYANT RANCH PREPACK]",
"spl_version": "101",
"published_date": "2026-05-04"
}
},
"productid": "71921-400_e4e6a5a8-f7be-4424-83f2-d6bb4d57443e",
"productndc": "71921-400",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "202053",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "EQ 2% BASE",
"product_no": "001",
"approval_date": "Sep 11, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DORZOLAMIDE HYDROCHLORIDE",
"proprietary_name": "Dorzolamide Hydrochloride Ophthalmic",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA202053",
"marketing_category": "ANDA",
"nonproprietary_name": "Dorzolamide Hydrochloride Ophthalmic",
"start_marketing_date": "20250507",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code S01EC03.
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